Home / Brand archive
20 reported ongoing
24 records in this archive. Latest source date Apr 28, 2025.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
There were reports of an increase in reactive negative controls and false positive results.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
There were reports of an increase in reactive negative controls and false positive results.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching ...
Class IIReported ongoing
Distribution: Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, DC, FL, GA, IN, IL, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OR, PA, SC, TN, TX, VA, WA, and WI; and foreign (OUS) c...
Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching ...
Class IIReported ongoing
Distribution: Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, DC, FL, GA, IN, IL, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OR, PA, SC, TN, TX, VA, WA, and WI; and foreign (OUS) c...
The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar." Abbott has identified an iss...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CAMBODIA, CAMEROON, CANADA...
Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
Class IIIReported ongoing
Distribution: US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
Class IIIReported ongoing
Distribution: US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
Class IIIReported ongoing
Distribution: US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.
Class IIReported ongoing
Distribution: Worldwide
The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconf...
Class IIReported ongoing
Distribution: x
Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
Class IIReported ongoing
Distribution: Worldwide
Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
Class IIReported ongoing
Distribution: Worldwide
The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of r...
Class IIReported ongoing
Distribution: US Distribution to state of: PA, a government account.
Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. It was found that the software...
Class IIReported ongoing
Distribution: Worldwide distribution.
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
Class IIReported ongoing
Distribution: Distribution was made to AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OK, PA, RI, TN, TX, WA, and WI. There was government distribution but no military di...
Incorrect optical calibration
Class IIReported completed
Distribution: There was only foreign distribution to Italy.
There is a potential for misquantitation high results of negative samples.
Class IIReported ongoing
Distribution: US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, E...
There is a potential for misquantitation high results for negative samples.
Class IIReported ongoing
Distribution: US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, E...
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
Class IIReported terminated
Distribution: US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MI, MO, NC, NJ, NY, OK, RI, SD, TX, WA, and WI.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 24 records, including 20 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.